The QBD Marketing Pow Wow is your go-to podcast for expert advice on propelling your business to new heights. Hosted by Rich, QBD’s Head of Lead Generation, this podcast delves into a wide array of marketing topics, including SEO, digital marketing, websites, print, creative content, branding & design and video. Each episode features insight from QBD’s experts and successful clients who share their experiences and top tips for growing a business in today’s digital landscape. Whether you’re a ...
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New guidelines from the USP and ICH will facilitate and accelerate adoption of Method Lifecycle Management (MLCM.) Experts will explore a variety of topics to help you understand and adopt MLCM including: key concepts like the Analytical Target Profile, regulatory changes that will impact your workflow, and case studies exploring the application and advantages of MLCM.
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Insights from Sterling Networks: Why Business Networking?
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Welcome to the latest episode of The Marketing Pow Wow! 🎙️ In this exciting episode, we had the pleasure of hosting Neil Davis, the Managing Director of Sterling Networks. Join us as Neil delves into the world of business networking, offering invaluable insights and strategies on how to build a strong and professional network. Episode Highlights: W…
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Content Mastery: The Key to Business Growth
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In this insightful episode of QBD Podcast: The Marketing Pow Wow, Rich sits down with Jon, the brilliant mind behind QBD's content strategy. Join us as we dive deep into the world of content and its pivotal role in driving business growth. Topics Covered: The Importance of Content: Why content is a cornerstone for modern businesses. Long-Form vs. S…
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Dive into the intriguing world of print media with our latest podcast episode, where we dissect the enduring relevance, effectiveness, and sustainability of print in today's digital-dominated landscape. In this enlightening discussion, we tackle the age-old question: is print still relevant in the digital age? Join us as we explore how print stands…
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Episode 14: Harness the Power of QbD Principles
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In this episode of the Method Lifecycle Management Podcast, join Dr. Pauline McGregor, Consultant and Owner at PMcG Consulting, as she discusses instrument quality by design and its role in the development of a successful AQbD plan.
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Episode 13: Components of a Successful AQbD Workflow
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Dr. Amanda Guiraldelli-Mahr, Scientific Affairs Manager at the United States Pharmacopeia, discusses the various components of the AQbD workflow including: the analytical target profile, method design, method validation, and performance verification.
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Episode 12: Janssen's stepwise approach to AQbD and vaccine development
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Waters welcomes back Dr. Ewoud van Tricht where he builds on the last episode when he discussed how Janssen approaches vaccine development with analytical quality by design (AQbD). Today, he elaborates on the specific steps of AQbD and the advantages gained.
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Episode 11: Applying AQbD Principles to Vaccine Development
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In today’s episode, host Arjan Timmerman talks with Janssen senior scientist, Dr. Ewoud van Tricht, about his recent article, “Better Methods for Better Vaccines”, and how he approaches vaccine development with an analytical quality by design approach.
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Episode 10: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3
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In our final installment of the nitrosamine podcast series, Dr. Teasdale concludes the topic discussing future regulatory guidance relative to nitrosamines and other mutagenic impurities.
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Episode 9: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2
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In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.
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Episode 8: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1
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In part one of a 3-part series on the Nitrosamine crisis, Dr. Andrew Teasdale of AstraZeneca discusses regulatory expectations, reporting requirements, and minimizing risk relative to solvent contamination.
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Episode 7: Data-driven Modeling Approaches to Improve Method Development
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Pfizer's Dr. Pankaj Aggarwal discusses the use of data-driven modeling to build quality and robustness into analytical methods.
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Episode 6: A History of MLCM and How it Will Evolve
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In Episode 6, Dr. Phil Nethercote discusses the factors that led to the beginnings of MLCM and QbD in 2004; his early days at GSK and the implementation of MLCM; and how Method Lifecycle Management might evolve.
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Episode 5: Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls
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Dr. Mark Argentine, Senior Research Advisor of Eli Lilly, discusses the benefits at Analytical Quality by Design, the challenges of identifying impurities and drug degradants, and regulatory and compliance barriers to enhance analytical controls.
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Episode 4: Guidance initiatives from the USP and ICH on Method Lifecycle Management
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Dr. Horacio Pappa, Director of the General Chapters Department, Global Science Division at USP, discusses the current regulatory landscape, guidance from USP and ICH, and implications for regulatory strategies relative to method lifecycle management.
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Episode 3: Verification and transfer of compendial methods
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In Episode 3, Dr. Pauline McGregor discusses how MLCM is applied to the verification and transfer of compendial procedures including the importance of developing, defining, and refining the analytical control strategy.
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Episode 2: Mitigating risk and improving drug quality with MLCM
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In our second episode, we examine a method lifecycle management approach in monitoring method performance and applying MLCM to address real world issues like nitrosamines (ni-tros-a-mine) in Valsartan.By Waters Corporation
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Episode 1: Advantages of MLCM over traditional approaches
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In our first episode, host Greg Martin of Complectors Consulting talks with Dr. Phil Borman of GSK about the advantages and influences of method lifecycle management including analytical quality by design, risk assessment tools, ICH guidances, and opportunities to kick off the approach in your organization.…
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Trailer: Method Lifecycle Management Podcast
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Thank you for your interest in the Method Lifecycle Management Podcast. Our aim is to bring together experts in method lifecycle management to discuss a variety of MLCM issues including, key concepts, regulatory drivers, challenges, adoption strategies, and real case studies. Our first episode will air on May 9 and focus on the factors driving adop…
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